Right VEntricular Contractile ReSERVE in Functional Tricuspid Regurgitation

Overview

Aim of the study is to investigate the prognostic value of right ventricular contractile reserve in patients with functional tricuspid regurgitation undergoing tricuspid valve repair or replacement.

Full Title of Study: “Prognostic Implication of Right Ventricular Contractile Reserve in Patients With Functional Tricuspid Regurgitation”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2022

Detailed Description

Chronic volume overload in patients with severe tricuspid regurgitation (TR) leads to right ventricular (RV) dilatation, fibrosis and eventually failure. RV dysfunction is an important determinant of mortality in patients undergoing tricuspid valve surgery. Aim of the current study is to investigate the prognostic utility of right ventricular contractile reserve in patients with severe TR undergoing surgical or interventional tricuspid valve repair or tricuspid valve replacement. RV contractile reserve will be assessed using semi-supine bicycle stress echocardiography. Echocardiographic parameters are prone to altered loading conditions, such as volume overload. Load independent RV contractility can only be measured using invasive pressure-volume-loop (PVL) analysis. Therefore RV PVL analysis will be done using conductance catheter in a subset of patients who undergo right heart catheterization for clinical evaluation of pulmonary hypertension. Aim of this sub study is the validation of non-invasively derived RV contractile reserve with load independent markers of intrinsic RV contractility.

Interventions

  • Diagnostic Test: Stress Echocardiography
    • Dynamic stress echocardiography using a cycle ergometer on a semi supine exercise table.
  • Diagnostic Test: Pressure volume loop analysis
    • Pressure volume loop analysis unsing conductance catheter measurements during right heart catheterization.
  • Procedure: Tricuspid valve repair or replacement
    • Tricuspid valve repair or replacement using a surgical or interventionale approach according to local heart team recommendation and patients’ preference.

Clinical Trial Outcome Measures

Primary Measures

  • Death or heart failure hospitalization
    • Time Frame: 6-12 month
    • Death or heart failure hospitalization according to right ventricular contractile reserve.

Secondary Measures

  • Death
    • Time Frame: 6-12 month
    • Death according to right ventricular contractile reserve.
  • Cardiovascular Death
    • Time Frame: 6-12 month
    • Cardiovascular Death according to right ventricular contractile reserve.
  • Heart Failure Hospitalization
    • Time Frame: 6-12 month
    • Heart Failure Hospitalization according to right ventricular contractile reserve.
  • Intrinsic RV contractility
    • Time Frame: Baseline
    • Correlation of RV contractile reserve with the slope of invasively derived right ventricular end systolic elastance.

Participating in This Clinical Trial

Inclusion Criteria

  • Severe functional tricuspid regurgitation. – Planned surgical or interventional tricuspid valve repair or replacement. – Able to cycle on a semisupine tilting exercise table. – Informed consent. Exclusion Criteria:

  • Coronary artery disease with significant ischemia. – Unstable Angina. – Myocardial infarction <4 month prior to inclusion. – Concomitant valvular heart disease (aortic, mitral or pulmonary valve) > mild-moderate. – Constrictive pericarditis. – Malignant disease with a life expectancy < 12 months. – Pregnancy. – Insufficient image quality on echocardiography.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Heart Center Leipzig – University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Philipp Lurz, Clinical Investigator, Professor, Managing Senior Physician – Heart Center Leipzig – University Hospital
  • Overall Official(s)
    • Philipp Lurz, MD, PhD, Principal Investigator, University of Leipzig
  • Overall Contact(s)
    • Philipp Lurz, MD, PhD, +49341865252022, philipp.lurz@medizin.uni-leipzig.de

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